ICU Patients
Conditions
Keywords
Glutamine, ICU patients, Critically ill, Nutrition
Brief summary
This is a prospective double-blinded placebo-controlled block randomized study in intensive care patients comparing intravenous glutamine supplementation to placebo. The hypothesis is an improvement of clinical outcome. The primary endpoint is a reduction in the Sequential Organ Failure Assessment (SOFA) score on day 7 of treatment.
Detailed description
This is a prospective double-blinded placebo-controlled block randomised study in intensive care patients comparing intravenous glutamine supplementation (0.285 g/kg body weight/24 h) to placebo. Inclusion criteria are patients treated for more than 3 days. Primary endpoint is a reduction in SOFA-score on day 7 of treatments. Secondary endpoints are: ICU-mortality, 6-months mortality, length of ICU stay, organ failure free days as well as reduction in SOFA-score on day 10 of treatment. Nutrition will be standardised so that not less than 80% of the target which is basal energy expenditure according to Harris & Benedict is given daily. Enteral nutrition is preferred, but a combination of enteral and parenteral nutrition is recommended to achieve the nutritional target. For statistical comparison non-parametric rank order statistics will be used. To detect a 0.75-point difference in the reduction of SOFA-score on day 7 of treatment, a total of 1,000 patients will be needed.
Interventions
DRUGGlutamine
Intravenous glutamine supplementation (0.285 g/kg body weight/24 h)
DRUGsaline (placebo)
NaCl 0.9 g/L
Sponsors
Scandinavian Critical Care Trials Group
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* admission to the ICU * decision to give the patient full nutrition * APACHE II score \> 10 at admission * age 18-85 years
Exclusion criteria
* readmission to the ICU after a previous ICU-stay in which the patient has been included into the study * subjects with any condition which in the opinion of the attending physician makes the subject unsuitable for inclusion * no informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A reduction in SOFA-score | Day 7 of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Mortality | ICU stay and 6 months |
| Length of ICU stay | ICU stay |
| Organ failure free days | ICU stay |
| Reduction in SOFA-score | Day 10 of treatment |
Countries
Sweden
Outcome results
None listed